Job Description
Our Client is looking for a Senior Regulatory Affairs Specialist with 8+ years of industry experience and 6+ years focused within EU MDR. This individual will serve as the primary regulatory representative on Product Engineering and Manufacturing teams. The main responsibilities include performing Medical Device Regulations (MDR) regulatory assessments to determine the gaps and impact on design/process/products, technical file updates, creation of Summary Technical Documentation (STED), preparing regulatory submissions, maintaining regulatory filings and licenses, design input/output documentation, identification of applicable standards and guidance documents, and interacting with regulatory agencies as needed. This professional needs to have extensive experience preparing and submitting regulatory filings for the above markets including IDEs, 510(k)s, non-filing justifications, Technical File creation/updates, Canadian License Applications
Required Skills
Regulatory Affairs
EU MDR
Gap Assessments
IDE / 510k Submissions
Project Management Skills
STED Template Creation – PLUS
Regulatory Intelligence exp – PLUS
Remote: Sr. Regulatory Affairs Position (232416)
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